Process automation vendor Emerson Process Management, Austin, Texas, has expanded its software library with new process analytical technology (PAT) tools designed to speed development and improve production of life-saving drugs. Emerson’s new high fidelity cell growth models and its multivariate process analytics accelerate product development, speed scale-up to full production, and enable real-time release of manufactured biological products.
Emerson’s most recent work is the development of models for mammalian cell processes that are currently in Beta testing. Cell growth models for bacterial, fungal, and yeast fermentations are available now. Previous studies indicate that the models can be used to prototype model predictive control of growth and product formulation rates, which can in some cases reduce batch times by 40 percent and improve yields by 10 percent.
{mosimages}Traditional development requires hundreds of trial batches, and then extensive data collection for final selection of processing conditions. Emerson’s new PAT tools shorten the time and cost of development, and use real-time data to improve quality and yield of released final product, the company says.
The new tools use off-line dynamic computer simulations of bioprocesses that can be run at up to 1000-times real time to determine optimum settings for real-time production. Also, for online operation, embedded analytics tools may be used to detect faults and predict end-of-batch values of quality parameters continuously in real time, helping to optimize batch process control and enable the efficiency of real-time release.
Emerson’s new PAT tools for bioreactor modeling are in a library of software modules that run in its DeltaV digital automation system. The model, configuration, and tools are used to create a “virtual plant” that can simulate batch execution faster than by physical experimentation. PAT tools are also being developed as embedded software in the DeltaV system to support on-line analytics. The DeltaV system is commonly used in product development and is the process management system embedded in the Broadley-James bioreactor family.
In other news, Emerson Process Management has been chosen to design and install its advanced PlantWeb digital plant architecture to digitally automate Shanghai CP Guojian Pharmaceutical Co.’s new API production suite, which will have the largest mammalian cell-culture system in Asia. Located in the Zhangjiang Hi-Tech Park in Shanghai, the new plant is expected to begin producing the first monoclonal antibody drugs in China by August 2008.Emerson was selected by M+W Zander, of Shanghai, the engineering procurement contractor, to design the plant’s automation approach to take advantage of PlantWeb architecture with Foundation Fieldbus instrumentation for networking intelligent process instrumentation. The PlantWeb approach will use its DeltaV digital automation system to also integrate variable frequency drives using DeviceNet, and all On/Off valves using AS-i (Actuator Sensor-interface) bus. Integration with the DeltaV systems speeds installation and commissioning for fast start-up, which is key for biopharmaceutical plants, and also includes DeltaV Batch software for process optimization and streamlined compliance.Shanghai CP Guojian Pharmaceutical Co. Ltd., develops and produces biopharmaceutical products for marketing in China and worldwide. The company concentrates on developing therapeutic humanized/human antibodies, vaccines, and diagnostic products for unmet medical needs relating to cancer and autoimmune diseases. Emerson Process Managementwww.emersonprocess.comShanghai CP Guojian Pharmaceutical Co.www.cpgj-pharm.com/en/index.asp
